Formulation Development Manager

Introduction

We are currently looking for a Formulation Development Manager to join a leading Pharmaceutical company based in the United Kingdom.

Important

Must have hands on and leadership experience in formulation development and scale up to GMP standards

The Job

Role Overview:
To lead the internal team responsible for developing and scaling up formulations on behalf of our client's clients. Particular focus will be on development of formulations which are suitable for late stage development and commercialisation. In addition the post holder will also contribute to the evaluation of novel formulation strategies to overcome pharmaceutical development challenges such as poor BCS characteristics with a particular focus on issues relating to GMP manufacture and later scale-up.
As the chemical and analytical development activities for many projects will also be carried out within our client, the post holder will work closely with colleagues in these areas to ensure that appropriate information is generated and evaluated so that pharmaceutical development strategies are based on sound scientific rationale.

Responsibilities:
Review technical information packages for new projects and ensure all relevant data is available to enable design and selection of an appropriate formulation
Provide expert formulation input to the design of experiments to investigate formulation and processing parameters for specific projects
Fully investigate all issues that arise during formulation developments/scale-up, determine the root cause and develop potential solutions
Design stability studies for formulated drug products to support formulation selection and applications to regulatory agencies
Ensure pharmaceutical development activities undertaken are in accordance with current regulatory and quality standards and that pharmaceutical development reports generated are suitable for inclusion in regulatory business
Ensure that the necessary skills and capabilities are present within the department to meet the needs of the business
Support business development activities to promote and grow the business ensuring that our client is recognised as an industry leader in the development and commercialisation of solid oral dose products

Requirements:
BSc degree (or equivalent) in Chemistry, Pharmacy, Formulation Chemistry, Chemistry with Formulation Chemistry or alternative related discipline ideally a Post Graduate (or equivalent) level qualification within a pharmaceutical development related discipline
Significant experience within a pharmaceutical development role
Previous experience and full working knowledge of current EU and US regulatory requirements for the development and manufacture of pharmaceutical drug products
Significant proven track record in the development of oral dosage forms
Proven track record in overcoming formulation challenges such as development and scale-up of manufacturing processes for poorly soluble compounds, modified release applications, FDC products etc.
Previous practical and managerial experience within a pharmaceutical development role
Demonstrable expertise in oral formulation development technologies
Effective communication skills (verbal, written, interpersonal and presentational)
Past experience in developing and manufacturing alternative dosage forms using a broad range of technologies